Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-31 @ 5:37 PM
Study NCT ID:
NCT04756934
Status:
UNKNOWN
Last Update Posted:
2021-02-16
First Post:
2021-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of HX008 Plus LP002 for the Treatment of Patients With Advanced Melanoma
Sponsor:
Taizhou HoudeAoke Biomedical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Study of Tolerance and Pharmacokinetics of HX008 (a Humanized Monoclonal Antibody Targeting PD-1) Plus LP002 (a Humanized Monoclonal Antibody Targeting PD-L1) in Patients With Locally Advanced or Metastatic Melanoma Who Have Experienced Progressed Disease in Previous Anti-PD-1 or PD-L1 Therapy.
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The subsequent treatment choices for the patients with advanced melanoma, who have failed the immune checkpoint inhibitor therapy of single agent. Evidences showed that PD-1 and PD-L1 signalling pathways are not redundant. Blocking both of them could produce synergistic effect. HX008 and LP002 are humanized monoclonal antibodies targeting PD-1 on T cells and PD-L1 on tumor cells respectively. In this study, participants with locally advanced or metastatic melanoma who have failed previous anti-PD-1 or PD-L1 will be administrated with HX008 plus LP002. The safety and preliminary efficacy will be evaluated.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: